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Last Updated: April 15, 2021

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Methylphenidate - Generic Drug Details

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What are the generic drug sources for methylphenidate and what is the scope of patent protection?

Methylphenidate is the generic ingredient in seventeen branded drugs marketed by Noven Pharms Inc, Neos Theraps Inc, Actavis Elizabeth, Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Breckenridge, Eywa, Novel Labs Inc, Quagen, Tris Pharma Inc, Ascent Pharms Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Dr Reddys, Heritage Pharma, Mylan, Osmotica, Par Pharm, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Aurolife Pharma Llc, Cediprof Inc, Mountain, Oxford Pharms, Prinston Inc, and Uspharma, and is included in eighty-three NDAs. There are fifty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has three patent family members in two countries.

There are thirty-two drug master file entries for methylphenidate. Two suppliers are listed for this compound.

Drug Prices for methylphenidate

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Drug Sales Revenue Trends for methylphenidate

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Recent Clinical Trials for methylphenidate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Miami VA Healthcare SystemPhase 4
VA New York Harbor Healthcare SystemPhase 4
Johns Hopkins UniversityPhase 4

See all methylphenidate clinical trials

Pharmacology for methylphenidate
Medical Subject Heading (MeSH) Categories for methylphenidate
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename Dosage Ingredient NDA Submissiondate
COTEMPLA XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL methylphenidate 205489 2017-09-01
DAYTRANA FILM, EXTENDED RELEASE;TRANSDERMAL methylphenidate 021514 2011-04-13

US Patents and Regulatory Information for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes   Start Trial   Start Trial   Start Trial
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-002 Apr 15, 2003 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-003 Aug 8, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Actavis Elizabeth METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208861-003 Dec 13, 2018 AB3 RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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